FDA (Drugs) recall action 94354

ARG Laboratories, Inc. recalled 11 products on 2024-06-05

The FDA (Drugs) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2024-06-05
Critical: 0
Units: 42,564

Why these products were recalled

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

Out of Specification for active ingredient

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

ModerateFDA (Drugs)··2024-06-05
Golden Tiger Pain Relieving Cream Recalled for Out-of-Specification Propylene Glycol
ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to use of a violative grade of propylene glycol during manufacturing that renders the active ingredient out of specification.
Product
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4
Category
Distribution
0 states
HighFDA (Drugs)··2024-06-05
Pain Relieving Cream Recalled Due to Out-of-Specification Active Ingredient
ARG Laboratories' Natural Pain Relieving Cream Golden Tiger is being recalled due to out-of-specification active ingredient and improper-grade propylene glycol used in manufacturing. No illnesses have been reported.
Product
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00005 5
Category
Distribution
0 states
HighFDA (Drugs)··2024-06-05
ALOE GATOR SPF 40+ Sunscreen Recalled for Out-of-Specification Active Ingredient
ARG Laboratories is recalling ALOE GATOR SPF 40+ sunscreen (4 oz, Lot 04023C1) distributed nationwide due to out-of-specification active ingredient levels that may affect product efficacy.
Product
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7
Category
Distribution
0 states
HighFDA (Drugs)··2024-06-05
Pain Wizard Topical Pain Relief Recalled for Out-of-Specification Active Ingredient
ARG Laboratories recalls Pain Wizard topical pain relief nationwide due to out-of-specification active ingredient and violative-grade propylene glycol used in manufacturing. No illnesses reported.
Product
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865
Category
Distribution
0 states
HighFDA (Drugs)··2024-06-05
Bull Frog SPF 50 Sunscreen Recalled for Out-of-Specification Active Ingredient
ARG Laboratories is recalling Bull Frog SPF 50 Amphibious Lotion nationwide due to the active ingredient being out of specification. Consumers with affected lots should not use the product and contact the manufacturer.
Product
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5
Category
Distribution
0 states
ModerateFDA (Drugs)··2024-06-05
FDA recalls Pain Wizard topical pain relief for ingredient specification issues
ARG Laboratories recalled Pain Wizard topical pain relief roll-on due to active ingredient out of specification and violative-grade propylene glycol used in manufacturing.
Product
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00010 9
Category
Distribution
0 states
HighFDA (Drugs)··2024-06-05
Pain Wizard topical pain relief recalled for manufacturing specification violation
ARG Laboratories is recalling Pain Wizard pain relief cream due to propylene glycol used in manufacturing not meeting pharmaceutical grade specifications. The product was distributed nationwide.
Product
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00019 2
Category
Distribution
0 states
ModerateFDA (Drugs)··2024-06-05
Aloe Gator SPF 40+ Sunscreen Recalled for Out-of-Specification Active Ingredients
ARG Laboratories is recalling 4,013 units of Aloe Gator SPF 40+ sunscreen (Lot 04023C1) distributed nationwide because the active ingredient does not meet specifications.
Product
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
Category
Distribution
0 states
HighFDA (Drugs)··2024-06-05
Golden Tiger Pain Relief Cream Recalled for Out-of-Specification Ingredients
ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to an active ingredient that does not meet specifications and violative grade propylene glycol used during manufacturing.
Product
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8
Category
Distribution
0 states
HighFDA (Drugs)··2024-06-05
Golden Tiger Pain Relief Cream Recalled for Out-of-Specification Active Ingredient
ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to the active ingredient being out of specification and improper grade propylene glycol being used during manufacturing.
Product
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2
Category
Distribution
0 states
ModerateFDA (Drugs)··2024-06-05
Pain Wizard topical pain relief recalled for out-of-specification manufacturing
ARG Laboratories recalls Pain Wizard pain relief cream nationwide due to manufacturing defect involving propylene glycol that did not meet specifications.
Product
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6
Category
Distribution
0 states